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ABBOTT Total Bilirubin - Indonesia BPOM Medical Device Registration

ABBOTT Total Bilirubin is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101020471. The device is manufactured by SEKISUI DIAGNOSTICS P.E.I., INC. from Canada, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : B
ABBOTT Total Bilirubin
Analysis ID: AKL 20101020471

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Canada

Authorized Representative

PT. ABBOTT PRODUCTS INDONESIA

AR Address

Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA

Registration Date

Feb 01, 2024

Expiry Date

Dec 18, 2028

Product Type

Clinical Chemistry Test System

Bilirubin (total or direct) test system (kit & cair)

Invitro Diagnostics

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